Senior QA Associate I

Purpose:
Primarily responsible for carrying out tasks related to core job responsibilities by providing quality consultation, auditing, and coordination of projects to maintain and improve the quality of work-related processes.

Responsibilities:
- Plan, organize, and lead study-specific inspections and/or internal system/process-based audits (some supervisory oversight).
- Review raw data, protocols, and research reports to ensure quality, integrity, and compliance with protocols, policies, procedures, and applicable governmental regulations; evaluate potential risk of compliance deficiencies.
- Provide guidance and training on GLP regulations and guidelines to Associate GLP auditors and functional area personnel.
- Assist the Inspection Management group on inspections by regulatory agencies.
- Prepare and present project progress reports to management.
- Participate on cross-functional project teams.
- Independent quality assurance auditor role; expected to demonstrate decision-making ability (supervisory review/oversight).
- Hybrid role with onsite work at Lake County Headquarters.

Qualifications:
- Bachelor’s degree (preferably life sciences or engineering).
- 4+ years’ experience in relevant fields (e.g., toxicology, bioanalytical laboratory, analytical chemistry, clinical pathology, Quality Assurance, and/or Regulatory Affairs).
- General understanding of GxP regulatory standards.
- Professional accreditation is desirable (e.g., ASQ CQM and/or CQA).

Benefits (if applicable): Paid time off, medical/dental/vision insurance, and 401(k); eligible for short-term incentive programs.